First FDA-approved vaccine for dengue prevention, but with restrictions
The US Food and Drug Administration yesterday announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas..
The approval was granted to Sanofi Pasteur, the vaccines unit of French pharma major Sanofi (Euronext: SAN).
The vaccine has been approved for use in several countries including the Philippines, Latin America and Asia, and the European Commission granted marketing authorization for Dengvaxia in December last year. It is also recommended by the World Health Organization, but a year ago the WHO said that it should only be used on individuals with proven prior dengue exposure.
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